AFF008E:Observational Follow-up Extension Study to Evaluate Long-term Safety and Tolerability of Immunization With AFFITOPE® PD01A Applied During AFF008 in Patients With Parkinson's Disease.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Affiris AG
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Tolerability and Safety
研究概览
简要总结
AFF008E is set-up to assess the long term effects of the 4 PD01A vaccinations that have been applied during AFF008 with regard to safety as well as immunological-, radiological and clinical activity. Accordingly, during AFF008E, no further vaccine dose will be applied. Instead, patients who were participating in AFF008 will be assessed for another 52 weeks at the occasion of 4 quarterly visits. This is offered to patients who received PD01A vaccinations but also to the patients who served as controls in AFF008. Thus, AFF008E will ensure standardized and controlled management of individuals who have received PD01A as part of AFF008, the Phase I study analyzing for the first time in humans this first in class candidate.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 41 Years 至 66 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Written informed consent signed and dated by the patient
- •Participation in AFF008
排除标准
- •History of questionable compliance to visit schedule; patients not expected to complete the clinical trial
- •Participation in the active treatment phase of another clinical trial except AFF008 within 13 weeks before Visit 1 and for the whole study duration
结局指标
主要结局
Tolerability and Safety
时间窗: 52 weeks
These will be based on the following parameters: * Withdrawal criteria (continuation decision) Number of patients who withdraw due to adverse events Reason for withdrawal * Occurrence of any serious adverse event possibly, probably or definitely related to the study vaccine at any time during the study. * Occurrence of any adverse events possibly, probably or definitely related to the study vaccine
次要结局
- Immunological and Clinical Efficacy(52 weeks)